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1.  Minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) in total hip arthroplasty (THA) patients 1 year postoperatively 
Acta Orthopaedica  2014;85(1):39-48.
Background and purpose
The increased use of patient-reported outcomes (PROs) in orthopedics requires data on estimated minimal clinically important improvements (MCIIs) and patient-acceptable symptom states (PASSs). We wanted to find cut-points corresponding to minimal clinically important PRO change score and the acceptable postoperative PRO score, by estimating MCII and PASS 1 year after total hip arthroplasty (THA) for the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and the EQ-5D.
Patients and methods
THA patients from 16 different departments received 2 PROs and additional questions preoperatively and 1 year postoperatively. The PROs included were the HOOS subscales pain (HOOS Pain), physical function short form (HOOS-PS), and hip-related quality of life (HOOS QoL), and the EQ-5D. MCII and PASS were estimated using multiple anchor-based approaches.
Results
Of 1,837 patients available, 1,335 answered the preoperative PROs, and 1,288 of them answered the 1-year follow-up. The MCIIs and PASSs were estimated to be: 24 and 91 (HOOS Pain), 23 and 88 (HOOS-PS), 17 and 83 (HOOS QoL), 0.31 and 0.92 (EQ-5D Index), and 23 and 85 (EQ-VAS), respectively. MCIIs corresponded to a 38–55% improvement from mean baseline PRO score and PASSs corresponded to absolute follow-up scores of 57–91% of the maximum score in THA patients 1 year after surgery.
Interpretation
This study improves the interpretability of PRO scores. The different estimation approaches presented may serve as a guide for future MCII and PASS estimations in other contexts. The cutoff points may serve as reference values in registry settings.
doi:10.3109/17453674.2013.867782
PMCID: PMC3940990  PMID: 24286564
2.  Feasibility of 4 patient-reported outcome measures in a registry setting 
Acta Orthopaedica  2012;83(4):321-327.
Background and purpose
Feasibility is an important parameter when choosing which patient-reported outcomes (PRO) to use in a study. We assessed the feasibility of PROs in a hip registry setting.
Methods
Primary total hip arthroplasty (THA) patients (n = 5,747) who had been operated on 1–2, 5–6, or 10–11 years previously were randomly selected from the Danish Hip Arthroplasty Register and sent 2 PRO questionnaires: 1 generic (EuroQoL-5D or SF-12 health survey) and 1 disease-specific (hip dysfunction and osteoarthritis outcome score (HOOS) or Oxford 12-item hip score). We compared response rates, floor and ceiling effects, missing items, and the need for manual validation of forms.
Results
4,784 patients (mean age 71 years, 57% females) were included (83%). The response rates ranged from 82–84%. Statistically significantly different floor and ceiling effects ranged from 0% to 0.5% and from 6.1% to 46%, respectively. Missing items ranged from 1.2% to 3.4%, and 0.8–4.3% required manual validation (p < 0.009). A hypothetical repeat study found that group sizes from 51 to 1,566 are needed for subgroup analysis, depending on descriptive factor and choice of PRO.
Interpretation
All 4 PROs fulfilled a priori set criteria, with the exception of ceiling effects. The high ceiling effects were attributed to postoperative administration and good outcome for THA. We conclude that all 4 PROs are appropriate for administration in a hip registry.
doi:10.3109/17453674.2012.702390
PMCID: PMC3427620  PMID: 22900909
3.  Quality of Data Entry Using Single Entry, Double Entry and Automated Forms Processing–An Example Based on a Study of Patient-Reported Outcomes 
PLoS ONE  2012;7(4):e35087.
Background
The clinical and scientific usage of patient-reported outcome measures is increasing in the health services. Often paper forms are used. Manual double entry of data is defined as the definitive gold standard for transferring data to an electronic format, but the process is laborious. Automated forms processing may be an alternative, but further validation is warranted.
Methods
200 patients were randomly selected from a cohort of 5777 patients who had previously answered two different questionnaires. The questionnaires were scanned using an automated forms processing technique, as well as processed by single and double manual data entry, using the EpiData Entry data entry program. The main outcome measure was the proportion of correctly entered numbers at question, form and study level.
Results
Manual double-key data entry (error proportion per 1000 fields = 0.046 (95% CI: 0.001–0.258)) performed better than single-key data entry (error proportion per 1000 fields = 0.370 (95% CI: 0.160–0.729), (p = 0.020)). There was no statistical difference between Optical Mark Recognition (error proportion per 1000 fields = 0.046 (95% CI: 0.001–0.258)) and double-key data entry (p = 1.000). With the Intelligent Character Recognition method, there was no statistical difference compared to single-key data entry (error proportion per 1000 fields = 6.734 (95% CI: 0.817–24.113), (p = 0.656)), as well as double-key data entry (error proportion per 1000 fields = 3.367 (95% CI: 0.085–18.616)), (p = 0.319)).
Conclusions
Automated forms processing is a valid alternative to double manual data entry for highly structured forms containing only check boxes, numerical codes and no dates. Automated forms processing can be superior to single manual data entry through a data entry program, depending on the method chosen.
doi:10.1371/journal.pone.0035087
PMCID: PMC3320865  PMID: 22493733

Results 1-3 (3)